A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Colorectal Cancer
- High Grade Glioma
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Each treatment cycle is 28 calendar days in duration. This is a basket study with five patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 mutation-positive malignant solid tumors status.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The Screening period (Day -30 to Day 1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to undergoing any study procedures. Each treatment cycle i...
The Screening period (Day -30 to Day 1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to undergoing any study procedures. Each treatment cycle is 28 calendar days in duration. There will be five patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status and prior treatment status: Cohort 1: Patients that have HER2-positive or HER2-negative breast cancer with HER2 activating mutations. Cohort 2: Patients that have colorectal cancer with HER2 activating mutations Cohort 3: Patients that have solid tumors (except NSCLC, breast cancer, or colorectal cancer) with HER2 activating mutations Cohort 4: Patients that have high-grade glioma with EGFR activating mutations Cohort 5: Patients that have solid tumors (except NSCLC or high-grade glioma) with EGFR activating mutations All patients will be treated 28 days per cycle until 24 months of treatment, disease progression, death, intolerable adverse events (AEs), or other protocol-specified reasons for patient withdrawal
Tracking Information
- NCT #
- NCT04172597
- Collaborators
- Not Provided
- Investigators
- Study Director: Lyndah Dreiling, MD Spectrum Pharmaceuticals, Inc